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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
510(k) Number K852343
Device Name DIG RADIOIMMUNOASSAY TEST SYSTEM
Applicant
M Nobird, Inc.
729 W. 16th St., C-4
Costa Mesa,  CA  92627
Applicant Contact MICHAEL R FALVO
Correspondent
M Nobird, Inc.
729 W. 16th St., C-4
Costa Mesa,  CA  92627
Correspondent Contact MICHAEL R FALVO
Regulation Number862.3320
Classification Product Code
DNL  
Date Received06/03/1985
Decision Date 07/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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